Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04443985 |
| Other study ID # |
MURA2019/249 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
August 10, 2020 |
Study information
| Verified date |
May 2022 |
| Source |
Mahidol University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Due to colorectal cancer is the fourth most common malignancy in the world. Some patients had
present locally advance stage and need to preoperative concurrent chemoradiation (CCRT)
before radical surgery. But predictor for pathologic complete response (pCR) after
preoperative CCRT remain unclear.
Objectives: To identify possible factor for predict of pCR of rectal cancer after
preoperative CCRT.
Description:
After permission was obtained from our institutional review board, a cohort of patients who
were diagnosed with rectal cancer and received chemoradiation between January 2011 to
December 2017 at Ramathibodi hospital, Bangkok were analyzed. Patients who were not received
neoadjuvant chemoradiation therapy, loss follow-up, incomplete data in the record, distant
organ metastasis and who was not received colorectal surgery were excluded as study flow
diagram. Age, sex, performance status, smoking, initial Hb level (g/mL), CEA level (ng/dL),
distance of tumor from anal verge, diagnostic variables, clinical T staging, preoperative
thickness and length from computer tomography scan (CT scan), organ metastasis before
treatment, histology, treatment course, and outcomes after treatment were collected and
analyzed.Total dose of radiation, interval time from CCRT to operation, and chemotherapy
regimens were also collected between and after treatment. After preoperative CCRT, the
radical rectal surgery was performed by eight experienced general surgeons and surgical
oncologist using open and laparoscopic techniques. Perioperative data were collected and
histology was evaluated by an experienced pathologists. For pathological classification,
pathological responses were divided in 2 groups i.e., pathologic complete response (pCR
group) and non-pCR group, (partial response, stable disease, and disease progression). Margin
of lesions were classified as proximal, distal and circumferential margins. Lymph nodes
status after surgery were specified as total lymph nodes harvested and positive lymph nodes.
